U.S. patent number 6,409,968 [Application Number 09/433,718] was granted by the patent office on 2002-06-25 for automatic analysis apparatus for biological fluid sample and automatic analysis method therefor.
This patent grant is currently assigned to Hitachi, Ltd.. Invention is credited to Katsuaki Takahashi.
United States Patent |
6,409,968 |
Takahashi |
June 25, 2002 |
Automatic analysis apparatus for biological fluid sample and
automatic analysis method therefor
Abstract
An automatic analysis apparatus comprises a reaction disk having
many reaction containers arranged on it. A sample is pipetted from
a sample container into the reaction containers, number of which is
equal to number of analysis items pre-instructed to be analyzed. At
the same time, the identical sample is pipetted into a backup
reaction container for backing up the inspection. After that,
analysis operation in regard to the instructed analysis items is
performed and a first analysis result is obtained. If it is judged
from the analysis result that re-analysis is necessary, the backup
sample in regard to the sample corresponding to the judgment is
pipetted from the backup reaction container into a new reaction
container. Then, the analysis operation in regard to the sample is
performed again.
Inventors: |
Takahashi; Katsuaki
(Hitachinaka, JP) |
Assignee: |
Hitachi, Ltd. (Tokyo,
JP)
|
Family
ID: |
18057701 |
Appl.
No.: |
09/433,718 |
Filed: |
November 4, 1999 |
Foreign Application Priority Data
|
|
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|
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Nov 5, 1998 [JP] |
|
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10-314795 |
|
Current U.S.
Class: |
422/64; 422/552;
422/63; 422/67; 422/73; 436/180; 436/807 |
Current CPC
Class: |
G01N
21/253 (20130101); G01N 35/00603 (20130101); G01N
35/025 (20130101); G01N 2035/00326 (20130101); G01N
2035/0472 (20130101); Y10S 436/807 (20130101); Y10T
436/2575 (20150115) |
Current International
Class: |
G01N
21/25 (20060101); G01N 35/02 (20060101); G01N
35/04 (20060101); G01N 35/00 (20060101); B32B
027/04 (); G01N 021/00 () |
Field of
Search: |
;422/64,67,100,63,73
;436/180,807,48 |
References Cited
[Referenced By]
U.S. Patent Documents
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|
|
4774055 |
September 1988 |
Wakatake et al. |
5501984 |
March 1996 |
Hofstetter et al. |
5698450 |
December 1997 |
Ringrose et al. |
5827479 |
October 1998 |
Yamazaki et al. |
5985215 |
November 1999 |
Sakazume et al. |
6261521 |
July 2001 |
Mimura et al. |
|
Foreign Patent Documents
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61-270661 |
|
Nov 1986 |
|
JP |
|
2-66461 |
|
Mar 1990 |
|
JP |
|
2-245665 |
|
Oct 1990 |
|
JP |
|
05-005694 |
|
Jan 1993 |
|
JP |
|
08-122337 |
|
May 1996 |
|
JP |
|
Primary Examiner: Fortuna; Ana
Attorney, Agent or Firm: Mattingly, Stanger & Malur,
P.C.
Claims
What is claimed is:
1. An automatic analysis apparatus comprising a sample transfer
device for transferring a sample container so as to pass through a
sample sampling position; a reaction disk having a plurality of
reaction containers; and a pipetter device for pipetting a sample
to be analyzed into the reaction container on said reaction disk,
and performing operation of analyzing the sampled sample, which
comprises
a control unit for controlling motion of said pipetter device so
that the sample to be analyzed is pipetted from the sample
container stopped at the sample sampling position into the same
number of the reaction containers as number of analysis items
pre-scheduled to be analyzed and at least one backup reaction
container, wherein
said control unit controls motion of said pipetter device so as to
hold a backup sample in said backup reaction container until a
result of a first analysis in regard to the sample to be analyzed
is obtained and to pipette part of the backup sample in said backup
reaction container into another reaction container for
re-analysis.
2. An automatic analysis apparatus according to claim 1, said
control unit controls the automatic analysis apparatus so as to
dilute the backup sample in said backup reaction container by
mixing with a diluent during operation of analysis in regard to the
samples to be analyzed pipetted into the reaction containers.
3. An automatic analysis apparatus according to claim 1, which
further comprises a plurality of analysis units each having a
reaction disk; and a pipetter device corresponding to each of said
analysis units, wherein
said control unit controls so as to stop sampling motion of the
backup sample when an amount of the sample contained in the sample
container before sampling is smaller than a sum of an amount of the
sample necessary for said plurality of analysis units and an amount
of the backup sample.
4. An automatic analysis method in which a sample is pipetted from
a sample container at a predetermined position into a reaction
container using a sample pipetter device, and the sample is reacted
with a reagent to analyze an analysis item, the method comprising
the steps of:
pipetting a backup sample from said sample container into another
reaction container on said reaction disk when the sample for a
first analysis is pipetted from said sample container into said
reaction container on said reaction disk;
pipetting the backup sample corresponding to the sample judged
necessary to be re-analyzed from a result of the first analysis
from said another reaction container into a new reaction container
on said reaction disk; and
performing operation of re-analysis using the sample in said new
reaction container.
Description
BACKGROUND OF THE INVENTION
The present invention relates to an automatic analysis apparatus
and an automatic analysis method and, more particularly to an
automatic analysis apparatus and an automatic analysis method for
analyzing analysis items of biological fluid samples such as blood
samples, urine samples or the like.
The automatic analysis apparatus for analyzing biological fluid
samples is generally constructed So as to analyze various kinds of
analysis items, and measures a reaction product produced by
reaction between the sample and a reagent in a measuring part. When
data of measured result of a sample shows an abnormal value,
re-analysis is automatically performed on the identical sample. In
order to position a sample container containing a sample at a
sample sampling position, there are a method that the sample
container is placed on a turntable and the turntable is moved, and
a method that the sample container is held in a rack and the rack
is moved using a belt conveyer or the like.
Japanese Patent Application Laid-Open No. 2-66461 discloses an
automatic analysis apparatus which uses a movable rack for moving
sample containers and has a function of re-analyzing samples. In
the prior art, a first conveyer lane is disposed between a rack
supply portion and a rack standby portion, and two analysis
portions each having a reaction disk are disposed along the first
conveyer lane, and a sample is pipetted to a reaction container in
a reaction disk at a sample sampling position on the first conveyer
lane. A second-conveyer lane for re-analysis is arranged in
parallel with the first conveyer lane. The standby portion has a
reciprocally movable rack transfer table, and receives a rack
finished sample sampling from the routine first conveyer lane to
hold the rack on the rack transport table until an analysis result
of the sampled sample is identified. The rack holding the sample
required to be re-analyzed is transferred from the standby portion
to the second conveyer lane to be sampled the sample for reanalysis
from the rack.
Further, Japanese Patent Application Laid-Open No.2245665 discloses
an automatic analysis apparatus which uses a turntable for moving
sample containers and is capable of performing re-analysis. The
prior art shows an example of an immunity analysis apparatus for
inducing an antigen-antibody reaction (immuno-reaction) using a
solid carrier. A sample pipetter device having a rotating arm has a
pair of disposable tips. At a first analysis, a sample is sucked
from a sample container on a sample table into the pair of the
disposable tips, and the sample in one of the pair of tips is
discharged into a reaction container in a reaction disk to be
analyzed. Necessity of a second analysis is judged after the first
analysis. If re-analyzing is necessary, the sample contained in the
other of the pair of tips is discharged into a reaction container
to perform the second analysis.
A ratio of necessity for re-analysis by judgment from a first
analysis result to each of analysis items of a sample is
approximately 5% of the total. Although most of samples are not
necessary to be re-analyzed as described above, it is highly
necessary to provide an automatic analysis apparatus with a
re-analyzing function. Particularly, in a case of an urgent sample
for which an analysis result must be urgently obtained, it is also
required to urgently obtain a re-analysis result.
In the case of Japanese Patent Application Laid-Open No.2-66461
described above, the rack holding the plurality of sample
containers is made stand by on the rack transport table in the
standby portion until first analysis results for all the samples on
the rack are obtained. Further, if there is only one sample judged
necessary to be re-analyzed among the plurality of samples on the
rack, the samples not necessary to be re-analyzed must be
transferred on the returning second conveyer lane by being held on
the rack together with the sample judged necessary to be
re-analyzed. Accordingly, the apparatus requires a complex
mechanism unit and an area to keep the rack in standby and to
transfer it back.
On the other hand, in the case of Japanese Patent Application
Laid-Open No.2-245665, the tips having a special shape are
necessary, and the sample pipetter device holding the disposable
tip for second analysis is occupied until the first analysis result
is obtained. Therefore, the efficiency of processing is extremely
decreased because the sample pipetter device can not be used to
pipette the other samples during that period.
SUMMARY OF THE INVENTION
An object of the present invention is to provide an automatic
analysis apparatus and an automatic analysis method which can
perform re-analysis without keeping a sample container after
sampling a sample for a first analysis at a standby portion until a
result of the first analysis of the sample is obtained.
Another object of the present invention is to provide an automatic
analysis apparatus and an automatic analysis method which can
perform re-analysis without occupying a sample pipetter device by a
sample until a result of a first analysis in regard to the sampled
sample is obtained.
A further object of the present invention is to provide an
automatic analysis apparatus and an automatic analysis method which
can be perform re-analysis without necessity of a special position
for keeping a sample container after sampling a sample for a first
analysis until a result of the first analysis of the sample is
obtained or without necessity of adding a special container.
A still further object of the present invention is to provide an
automatic analysis apparatus having a plurality of analysis units
which can perform re-analysis of a sample by an analysis unit used
first even if a sample container finishing sampling of the sample
for the analysis unit used first is transferred to an analysis unit
used next before an analysis result of the sample by the analysis
unit used first is not obtained yet.
An automatic analysis apparatus which the present invention is
applied to comprises a sample transfer device for positioning a
sample container containing a sample at a sample sampling position;
a reaction disk having a plurality of reaction containers arranged
on it; and a pipetter device for pipetting a sample to be analyzed
into the reaction container on the reaction disk, and performs
operation of analyzing the sampled sample sampled in the reaction
container on the reaction disk. The sample container transfer
device used may be a rotary type such as a turntable or a type
transferring the sample containers on a transfer line by holding
them in a rack. There are provided one or more than two analysis
units having the reaction disk. In a case where two or more of the
analysis units are provided, the sample pipetter devices are
respectively provided corresponding to the analysis units.
A concept of the present invention is that an automatic analysis
apparatus comprises a control unit for controlling motion of the
sample pipetter device so that the sample pipetter device pipettes
a backup sample from the sample container at the sample sampling
position into one reaction container on the reaction disk when the
sample to be analyzed is pipetted, and manages the one reaction
container so as to hold the backup sample in the one reaction
container until a first analysis result in regard to the sample to
be analyzed is obtained, and controls motion of the sample pipetter
device to pipette part of the backup sample in the one reaction
container into another reaction container based on a judgment that
re-analysis to the first analysis result is necessary.
In the automatic analysis apparatus, it is preferable that during
operation of analysis in regard to the samples to be analyzed
pipetted into the reaction containers, the backup sample in the one
reaction container is diluted by mixing with a diluent to obtain a
sample diluted in a predetermined ratio (a diluted sample) in order
to prepare sample sampling for re-analysis.
Another concept of the present invention is that an automatic
analysis apparatus is constructed so that in a case where the
sample in the sample container positioned at the sample sampling
position to be pipetted is an urgent sample, a backup sample is
pipetted from the sample container at the sample sampling position
into one reaction container on the reaction disk when the sample to
be analyzed is pipetted, and it is judged whether or not a first
analysis result in regard to the sampled sample to be analyzed
requires to be re-analyzed, and the backup sample is pipetted from
the one reaction container into another reaction container on the
reaction disk if the re-analysis is required, and then analysis
operation of the re-analysis to the sample pipetted in the another
reaction container is performed.
In a case where the automatic analysis apparatus comprises a
plurality of analysis units, pipetting motion of the backup sample
may be stopped when an amount of the sample contained in the sample
container before sampling is smaller than a sum of an amount of the
sample necessary for the plurality of analysis units and an amount
of the backup sample.
A further concept of the present invention is that an automatic
analysis apparatus comprising a plurality of analysis units and a
sample container transfer mechanism capable of positioning the
sample container containing the sample at a sample sampling
position provided corresponding to each of the analysis units,
wherein the plurality of analysis units include at least an immune
item analysis unit and a biochemical item analysis unit; a sample
container containing a specific sample requiring analyses by both
of the immune item analysis unit and the biochemical item analysis
unit being positioned at the sample sampling position for the
immune item analysis unit before being positioned at the sample
sampling position for the biochemical item analysis unit; at the
immune item analysis unit, the corresponding sample pipetter device
pipetting a backup sample from the sample container at the sample
sampling position into the reaction container on the reaction disk
of the immune item analysis unit when the sample to be analyzed is
pipetted; the sample for the re-analysis being pipetted from the
reaction container containing the backup sample into another
reaction container on the reaction disk of the immune item analysis
unit when a first analysis result in regard to the sample to be
analyzed of the immune item analysis unit requires re-analysis.
BRIEF DESCRIPTION OF DRAWINGS
FIG. 1 is a schematic view showing the overall construction of an
embodiment of an automatic analysis apparatus in accordance with
the present invention.
FIG. 2 is a view explaining the pipetting motion of samples in the
embodiment of FIG. 1.
FIG. 3 is a view explaining the pipetting motion of samples at a
midway through the process.
FIG. 4 is a view explaining the pipetting motion of samples.
FIG. 5 is a view explaining the pipetting motion of samples.
FIG. 6 is a view explaining the diluting motion of a backup
sample.
FIG. 7 is a view showing a state of a reaction disk at a time 10
minutes after starting pipetting motion.
FIG. 8 is a view explaining the pipetting motion of a backup
sample.
FIG. 9 is a view explaining the pipetting motion of a backup
sample.
FIG. 10 is a view explaining modifications of the embodiment of
FIG. 1.
FIG. 11 is a schematic view showing the overall construction of
another embodiment in accordance with the present invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
FIG. 1 shows the overall construction of an embodiment of an
automatic analysis apparatus in accordance with the present
invention. This embodiment comprises one analysis unit having a
reaction disk 2 on which a plurality of transparent reaction
containers 1 are arranged. The reaction disk 2 is rotatable both
clockwise and counterclockwise.
Referring to FIG. 1, a plurality of sample containers 5 containing
samples are arranged on a sample disk 11 and each of the sample
containers is positioned at a sample sampling position by rotating
motion. After pipetting motion of the samples to all the sample
containers, the sample disk 11 is exchanged for a new sample disk
on which samples not transacted are set. A computer 12 controls
motion of each mechanism in the automatic analysis apparatus
through an interface 14. The rotating motion of the sample disk 11
is controlled so that corresponding sample containers 5 are stopped
at the sample sampling position while each of the samples is
pipetted to the reaction containers number of which is equal to
number of instructed analysis items and to a reaction container for
backup. A sample pipetting device 6 having a rotatable arm for
holding a pipette nozzle 15 performs operation of sucking and
discharging the sample using the pipette nozzle corresponding to
motion of a sample pump 16 connected to the pipette nozzle 15. Each
of the samples is pipetted to the reaction container 1 for each
analysis item by the sample pipetter device 6.
The reaction disk 2 is rotated so that each of the reaction
containers 1 passes through a sample adding position, a reagent
adding position, a mixing position, an optical measuring position
and a container washing position. The reaction container 1
receiving a sample from the pipette nozzle 15 at the sample adding
position is moved to the reagent adding position to be added with a
reagent corresponding to an analysis item using a reagent pipetter
device 7. A plurality of reagent bottles 21 prepared for many kinds
of analysis items are selectively positioned at a reagent sucking
position by a reagent disk 8. Positioning of each of the reagent
bottles can be performed by rotating the reagent disk 8
corresponding to an analysis item allocated to a reaction container
stopped at the reagent adding position. The pipette nozzle of the
reagent pipetter device 7 performs pipetting motion of sucking and
discharging a reagent by action of a reagent pump 18.
The reaction container 1 receiving the reagent is moved to the
mixing position to mix the mixture of the sample and the reagent
using a mixing device 19. A diluent bottle 26 (FIG. 6) containing a
diluent is also placed on the reagent disk 8. The reaction
container 1 holding the reaction solution of the sample and the
reagent is moved so as to move across a light beam at the optical
measuring position of a photometer 3. By doing so, an optical
property of the reaction solution having a reaction product is
detected by the photometer 3, and the detected signal is input to
the computer 12 by way of an analogue/digital converter 17 through
the interface 14. The computer 12 calculates a concentration of the
analysis item based on a calibration curve prepared in advance, and
the analysis result is printed out to a printer 22 and/or displayed
on a screen of a CRT 23.
The reaction container 1 completed measurement is moved to the
washing position to discharge the reaction solution and to be
washed with a detergent solution and water at a reaction container
washing unit 9 connected to a container washing pump 25, and the
cleaned reaction container is moved toward the sample adding
position to receive a new sample. A program for operating each of
the mechanisms is stored in a floppy disk memory which is read
using an FD drive 24. Analysis conditions such as selection of
analysis items for each sample, an amount of pipetting a sample for
each analysis item, an amount of pipetting each reagent, a dilution
ratio and an amount of pipetting a sample for re-analysis and so on
can be input and selected from an operation panel 13 in an
interactive manner with a screen on the CRT 23.
Operation of automatic re-analysis in the embodiment of FIG. 1 will
be described below, referring to FIG. 2 to FIG. 9. The description
will be made here by assuming an operation that the reaction disk 2
repeats a cycle of rotating by one turn and one container distance
and stopping during normal analysis operation. The photometer 3
optically measures an absorbance of a reaction solution in each of
the reaction containers instantaneously when the row of the
reaction containers 1 move across the light beam 4.
Referring to FIG. 2, it is assumed that a sample container 5a
containing a sample a pre-instructed to be analyzed in three kinds
of analysis items of, for example, .alpha., .beta. and .gamma. is
positioned and stopped at the sample sampling position S of the
sample disk 11, and that a reagent bottle 21 used for the precedent
sample is stopped at the reagent sucking position R of the reagent
disk 8. The reaction disk 2 positions and stops a reaction
container 1A allocated to analyze the analysis item a at the sample
adding position. In this state, the sample pipetter device 6
rotates the pipette nozzle above the sample container 5a and
inserts the nozzle tip into the sample inside the sample container
5a to suck and hold the sample a inside the pipette nozzle. Then,
the sample pipetter device 6 rotates the pipette nozzle above the
reaction container 1A to add the sample a of 2 .mu.l as a sample
for first analysis of the analysis item a into the reaction
container 1A.
After such pipetting operation, the reaction disk 2 is rotated by
one turn and one container distance to position and stop a reaction
container 1B at the sample adding position. At the same time, the
reagent disk 8 positions the reagent bottle 21a for the analysis
item .alpha. at the reagent sucking position. The sample disk 11 is
not moved, and the sample container 5a is kept stopping. By doing
so, the state shown in FIG. 3 is obtained.
Referring to FIG. 3, the sample pipetter device 6 pipettes the
sample a for a first analysis of the analysis item .beta. of 3
.mu.l from the sample container 5a into the reaction container 1B.
At the same time, the reagent pipetter device 7 pipettes a preset
amount of the reagent for the analysis item .alpha. from the
reagent bottle 21a into the reaction container 1A stopped at the
reagent adding position. After that, the reaction disk 2 is rotated
by one turn and one container distance to position and stop the
reaction container 1C at the sample adding position. At the same
time, the reagent disk 8 positions the reagent bottle 21b for the
analysis item .alpha. at the reagent sucking position. The sample
disk 11 is not moved yet, and the sample container 5a is kept
stopping. By doing so, the state shown in FIG. 4 is obtained.
Referring to FIG. 4, the sample pipetter device 6 pipettes the
sample a for a first analysis of the analysis item .gamma. of 4
.mu.l from the sample container 5a into the reaction container 1c.
At the same time, the reagent pipetter device 7 pipettes a preset
amount of the reagent for the analysis item .beta. from the reagent
bottle 21a into the reaction container 1B stopped at the reagent
adding position. Successively, the reaction disk 2 is rotated by
one turn and one container distance to position and stop the
reaction container 1D at the sample adding position. At the same
time, the reagent disk 8 positions the reagent bottle 21c for the
analysis item .gamma. at the reagent sucking position. The sample
disk 11 is not moved yet, and the sample container 5a containing
the sample a is kept stopping. By doing so, the state shown in FIG.
5 is obtained.
In FIG. 5, the reaction container 1D on the reaction disk 2 is
allocated to receive a backup sample for insuring against a case of
necessity of the sample a for re-analysis. That is, in a case of
performing first analyses on three items, one or more additional
reaction containers are used for receiving the sample a in addition
to the three reaction containers for the predetermined analysis
items. In other words, the sample pipetter device 6 pipettes the
identical sample to reaction containers number of which is larger
than number of the instructed analysis items by one or more.
Referring to FIG. 5, the sample pipetter device 6 pipettes the
sample a as a backup sample a of 80 .mu.l from the sample container
5a into the reaction container 1D. At the same time, the reagent
pipetter device 7 pipettes a preset amount of the reagent for the
analysis item .gamma. from the reagent bottle 21a into the reaction
container 1C stopped at the reagent adding position. Successively,
the reaction disk 2 is rotated by one turn and one container
distance to position and stop the reaction container 1E at the
sample adding position. At the same time, the reagent disk 8
positions the diluent bottle 26 at the reagent sucking position.
Further, at the same time, the sample disk 11 is rotated so that a
sample container 5b containing the next sample b is positioned at
the sample sampling position. By doing so, the sample to be sampled
is changed, and the state shown in FIG. 6 is obtained.
Referring to FIG. 6, the sample pipetter device 6 pipettes the
sample b for a first analysis of the analysis item .gamma. of 3
.mu.l from the sample container 5b into the reaction container 1E.
At the same time, the reagent pipetter device 7 pipettes the
diluent of 160 .mu.l from the diluent bottle 26 into the reaction
container 1D stopping at the reagent adding position. Thereby, the
sample of 80 .mu.l and the diluent of 160 .mu.l are mixed to dilute
the backup sample to three times. When dilution of the backup
sample in regard to the sample a is unnecessary, motion of the
reagent pipetter device is controlled so as to add the diluent by
the computer 12 as a controller.
The sample b is pipetted to the reaction containers for the other
analysis items, and at the same time the backup sample is also
pipetted to one reaction container. Further, the samples following
the sample b are pipetted into the reaction containers on the
reaction disk 2 for instructed analysis items and for the backup
samples. At 10 minutes after starting the pipetting of the sample
a, a first analysis result in regard to each of the analysis items
of the sample a can be obtained. At that time, the state of the
reaction disk 2 is as shown in FIG. 7.
The controller (computer 12) compares each of the first analysis
results for the analysis items .alpha., .beta. and .gamma. with
reference values to judge whether or not re-analysis for each of
the analysis items is necessary. For example, when a first analysis
result shows an abnormally high value or an abnormally low value,
it is judged that re-analysis is necessary. It is assumed here that
it is judged in regard to the sample a that only the re-analysis
for the analysis item .gamma. is necessary, and that re-analyses
for the analysis items .alpha. and .beta. are unnecessary.
According to the judgment, the reaction disk 2 is moved from the
state of FIG. 7 to the state of FIG. 8. That is, the reaction disk
2 is rotated counterclockwise (in the normal direction) so as to
position and stop the reaction container 1D containing the diluted
backup sample a of 240 .mu.l from a halfway position as shown in
FIG. 7 to the sample adding position as shown in FIG. 8. After
that, the tip of the pipette nozzle 15 of the sample pipetter
device 6 is inserted into the diluted sample in the reaction
container 1D to suck and hold a preset amount of the sample in the
pipette nozzle, and then the pipette nozzle is moved upward. In
that state, the reaction disk 2 is rotated counterclockwise (in
reverse direction) so as to be recovered to the state of FIG. 7 and
stopped. This state is shown in FIG. 9.
In the state of FIG. 9, a vacant reaction container 1F is
positioned at the sample adding position. The tip of the pipette
nozzle 15 of the sample pipetter device 6 is moved downward into
the reaction container 1F to discharge the diluted sample held in
the pipette nozzle by 4 .mu.l during stopping of the reaction disk,
the reaction container 1A finishing measurement is washed by the
reaction container washing unit 9 to be cleaned. After that, the
reaction disk 2 is normally moved, and the reaction container 1F
containing the sample a for re-analysis is added with the reagent
for the analysis item .gamma., and mixed, and the reaction solution
is optically measured.
In regard to the samples following the sample b, when the first
analysis results in regard to the analysis items are obtained, it
is judged whether or not the re-analysis is necessary. Part of the
backup sample in regard to an analysis item judged necessary to be
re-analyzed is pipetted into a new reaction container to perform
operation of analysis transaction for the re-analysis. Motion of
the sample disk, the reaction disk, the sample pipetter device, the
reagent pipetter device and so on is controlled by the computer
12.
It is not necessary that the operation according to the present
invention of holding the backup sample for re-analysis in a
reaction container is applied to all the samples employ. That is,
the automatic analysis apparatus may be constructed so that in
regard to most of general samples for routine analyses, the
original sample containers are held in the sample disk or a rack,
and the original sample positioned container is positioned
corresponding to the necessity, similar to the conventional
apparatus; and the present invention is applied to an urgent
sample. By doing so, in regard to the urgent sample, the backup
sample becomes naught if the re-analysis is judged to be
unnecessary for any of the analysis items. However, when the
re-analysis is judged to be necessary, the result of the
re-analysis can be obtained in a very short time, and a ratio of
using the reaction containers to the backup sample on the reaction
disk can be lowered.
In that case, the sample container containing the urgent sample is
set in an urgent sample area predetermined on the sample disk 11 of
FIG. 11 or an urgent sample area provided on a moving path of the
pipette nozzle. The computer 12 recognizes request of an urgent
sample by detecting setting of the sample container in the area
using a container detector or by selecting of an urgent sample
measuring instruction button by an operator. Thereby, the sample
pipetter device 6 moves the pipette nozzle to a sample sampling
position of the urgent sample area to pipette the sample into
reaction containers corresponding to the instructed analysis items
and to pipette the sample for backup into a reaction container.
Operation after that is performed similarly to that described
above.
FIG. 10 is a view explaining three types of modifications of the
embodiment of FIG. 1. A first modification is that a motion range
of the sample pipetter device is changed instead of rotating the
reaction disk in the normal direction and the inverse direction in
order to pipette the sample for re-analysis as shown in FIG. 8 and
FIG. 9. In this case, the sample pipetter device 6 having the arm
rotatable around a rotating center 10A is operated so that samples
to be analyzed for a first analysis and a backup sample are
pipetted from a sample container 5 into reaction containers
positioned at the position P, and so that the backup sample is
pipetted from a reaction container containing the backup sample at
a position Z into a vacant reaction container at the position
P.
A second modification is that two sample pipetter devices are
provided. In this case, one of the sample pipetter devices 6 has
the arm rotatable around the rotating center 10A to pipette samples
to be analyzed for a first analysis and a backup sample into
reaction containers positioned at the position P. The other of the
sample pipetter devices has an arm rotatable around the rotating
center 10B to pipette a backup sample from a reaction container
containing the backup sample at a position X into a reaction
container at the position P.
A third modification is that one sample pipetter device is
constructed so that the rotating center of the arm is horizontally
movable. In this case, the reference rotating center of the sample
pipetter device 6 is moved so as to be set at the positions 10A,
10B and 10C. For example, a backup sample for the analysis item
.alpha. is sucked when the reaction container 1D is at the position
X and discharged into a new reaction container at the position P,
and in the next cycle a backup sample for the analysis item .beta.
is sucked when the reaction container 1D is at the position Y and
discharged into a new reaction container at the position P, and in
the further next cycle a backup sample for the analysis item
.gamma. is sucked when the reaction container 1D is at the position
Z and discharged into a new reaction container at the position P.
Then, the reaction container 1D is washed. Number of the positions
may be several (three positions X, Y, Z in the figure) since the
cases required to be re-analyzed occur in not so many items. When
the number of the position is short, the reaction container 1D is
passed through without being washed, and pipetting may be performed
when the reaction container 1D comes to the position X, Y or Z in
the second turn at approximately 12 minutes after.
Description will be made below on another embodiment to which the
present invention is applied. Analyses on immune analysis items
such as CEA, HCG, TSH, T4 extremely avoid being mutually
contaminated (carryover) between samples because the analyses deal
with infectious diseases. In analyses on biochemical analysis items
such as CRE, TP, UA, GOT, a common pipette nozzle is repetitively
used by being washed because the carryover between samples is not
so severe. On the contrary, in an immune item analysis apparatus,
the disposable nozzle tip and the reaction container are replaced
by new ones every time when the sample is changed.
FIG. 11 is a schematic view showing the overall construction of an
automatic analysis apparatus comprising both of an immune item
analysis unit and a biochemical item analysis unit. Although FIG.
11 shows an example comprising two analysis units, three or more
analysis units may be disposed. In the analysis units, the
identical sample container is positioned at a sample sampling
position for each of the analysis units so that a sample may be
sampled from the identical sample container.
Referring to FIG. 11, the immune item analysis unit 20 and the
biochemical item analysis unit 30 are arranged along a transfer
line 40 for transferring a rack from a rack supply unit 35 to rack
housing unit 38. The racks 52 holding a plurality of sample
containers containing samples are placed side by side in two rack
trays of the rack supply unit 35 and transferred pitch by pitch
toward the transfer line 40. Each of the racks transferred to the
transfer line 40 is once stopped at a position before a sample
information reading unit 36 , and sample related information
attached on each of the sample containers and the rack is read by a
bar code reader 37 to be transmitted to a controller 50. On the
other hand, the rack housing unit 38 comprises tow rack trays, and
receives the rack 52 finishing sample pipetting transaction of at
least one of the analysis units from the transfer line 40. Moving
and stopping operation of a belt conveyer in the transfer line is
controlled by the control unit 50.
A rack holding a sample instructed to be analyzed with immune items
is dropped in at a rack receiving area 41 of the immune item
analysis unit 20, and the sample is sampled for the desired
analysis items at the sample sampling position 28. A rack holding a
sample instructed to be analyzed with biochemical items is dropped
in at a rack receiving area 42 of the biochemical item analysis
unit 30, and the sample is sampled for the desired analysis items
at the sample sampling position 32. A rack holding a sample
instructed to be analyzed with both immune items and biochemical
items is dropped in at the rack receiving areas 41, 42 of the
analysis units 20, 30, and the sample is sampled. The rack
necessary to be dropped in at both of the immune item analysis unit
20 and the biochemical item analysis unit 30 is preferentially
dropped in at the immune item analysis unit 20 first before dropped
in at the biochemical item analysis unit 30.
The immune item analysis unit 20 comprises the rack receiving area
41, an exchanger for exchanging a used reaction container to a new
one, a reaction disk 45 arranging disposable reaction containers
supplied from the exchanger thereon, a sample pipetter device 44
for pipetting from a sample container on a rack at the sample
sampling position 28 to a reaction container on the reaction disk
45, a reagent disk 46 mounting reagent bottles corresponding to
analysis items, and a reagent pipetter device 47 for pipetting a
reagent from the reagent bottle to the reaction container. The
sample pipetter device 44 is constructed so that a disposable
pipette nozzle tip can be attached to an end of a pipette tube held
by a rotatable arm, and that the used pipette nozzle tip can be
detached from the pipette tube when pipetting transaction for one
sample is finished. The immune item analysis unit 20 comprises a
supply unit for supplying many pipette nozzle tips of such a type
and a disposing area of the used nozzle tips.
On the other hand, the biochemical item analysis unit 30 comprises
the rack receiving area 42, a reaction disk 55 arranging reaction
containers repetitively used by being washed, a sample pipetter
device 54 for pipetting a sample from a sample container on a rack
at the sample sampling position 32 to a reaction container on the
reaction disk 55, a reagent disk mounting various kinds of reagent
bottles thereon, and a reagent pipetter device 57 for pipetting a
reagent from the reagent bottle to the reaction container. A
pipette nozzle of the sample pipetter device 54 is repetitively
used be being washed. Each of the both analysis units comprises a
measuring unit for a reaction solution or a reaction product.
Rack transfer mechanisms 27, 31 operate so as to transfer the rack
from the transfer line 40 to the rack receiving areas 41, 42,
respectively, and rack transfer mechanisms 29, 33 operate so as to
transfer the rack after pipetting transaction from the rack
receiving areas to the transfer line 40, respectively.
In the embodiment of FIG. 11, the function of pipetting a backup
sample for re-analysis to a reaction container on the reaction disk
is provided only to the immune item analysis unit 20, but not to
the biochemical item analysis unit 30. The function may be provided
to the both analysis units, if necessary. Before performing
pipetting transaction of a sample in the biochemical item analysis
unit 30, in the immune item analysis unit 20 pipetting for
instructed analysis items and pipetting of the backup sample in
regard to a sample contained in the corresponding sample container
on the rack are performed. Therefore, even if it is judged from the
first analysis result of each item in the immune item analysis unit
20 that re-analysis is necessary, it is not necessary that the
sample rack once dent out from the rack receiving area 41 is again
carried into the rack receiving area 41 through the transfer line
40 to perform pipetting the sample for re-analysis.
Accordingly, the rack finished pipetting transaction in the immune
item analysis unit 20 can be immediately transferred to the next
biochemical item analysis unit 30, and there is no need to keep the
rack standing by at a special area until the first analysis result
is obtained. Further, since the rack finished pipetting transaction
in the biochemical item analysis unit 30 can be avoided from
pipetting transaction of the sample for re-analysis in the immune
item analysis unit 20, an effect of carryover between samples can
be skillfully excluded.
Pipetting operation of the backup sample in the immune item
analysis unit 20 will be not described here in detail in order to
avoid repetition because it is similar to that in the case of the
above-mentioned embodiment of FIG. 1. To make a long story short,
in the immune item analysis unit 20, when the sample pipetter
device 44 delivers a sample in a sample container on a rack
positioned at the sample sampling position 28 to reaction
containers on the reaction disk 45 for the first analysis, the
identical sample is delivered to one reaction container on the
reaction disk 45 as a backup sample. Then, when the control unit
judges based on the result of the first analysis that re-analysis
is necessary, the sample for the re-analysis is sampled from the
one reaction container containing the backup sample to another
reaction container on the reaction disk of the immune item analysis
unit.
In the automatic analysis apparatus to which the present invention
is applied, in a case where the automatic analysis apparatus
comprises a plurality of analysis units each having a reaction disk
and a sample pipetter device corresponding to each of the analysis
units, when a fluid amount of a sample contained in a sample
container before sample sampling is smaller than a total amount of
an amount of sample to be analyzed and an amount of a backup sample
required in the plurality of analysis units, operation of sampling
the backup sample is stopped. By doing so, it is avoidable that the
amount of the sample is short due to sampling of the backup
sample.
According to the present invention, in regard to a sample having a
possibility of re-analysis, a sample container after sampling the
sample for a first analysis is not kept at a special standby
portion until a result of the first analysis of the sample is
obtained, and a sample pipetter device is not occupied by a sample
until a result of a first analysis in regard to the sampled sample
is obtained. Further, in a case of an automatic analysis apparatus
comprising a plurality of analysis units, reanalysis of a sample
can be performed by an analysis unit used first even if a sample
container finishing sampling of the sample for the analysis unit
used first is transferred to an analysis unit used next before an
analysis result of the sample by the analysis unit used first is
not obtained yet.
* * * * *